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Completed

NCT Number: NCT04006145

A Phase 2 Study of Elobixibat in Adults With NAFLD or NASH

Double-blind, randomized, placebo-controlled study to explore the efficacy and safety of elobixibat compared to placebo in adults with NAFLD (nonalcoholic fatty liver disease) or NASH (nonalcoholic steatohepatitis)

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Key information

Conditions

NAFLD Digestive System Diseases Fatty Liver Liver Diseases NASH Non-alcoholic Fatty Liver Disease

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hope Clinical Research, Canoga Park, California, United States

Loading trial locations.

About this study

A total of 15 investigators at 15 sites received institutional review board (IRB)/ethics committee (EC) approval to participate in this study and enrolled at least 1 participant.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • Have a current biopsy-confirmed NASH within 6 months of screening or a suspected diagnosis of NAFLD/NASH
  • Screening magnetic resonance imaging-proton density fat fraction (MRI-PDFF) with ≥10% liver steatosis
  • Fasting serum low density lipoprotein-cholesterol (LDL-C) >130 mg/dL at Screening, >110 mg/dL on lipid-lowering medications

Key Exclusion Criteria:

  • Body mass index (BMI) <25 kg/m2
  • Fibrosis-4 index (Fib-4) >2.6
  • Any of the following laboratory abnormalities:
  • alanine aminotransferase (ALT) >5 × upper limit of normal (ULN) or aspartate aminotransferase (AST) >5 × ULN
  • International normalized ratio (INR) ≥1.3, unless on anticoagulant therapy
  • Total bilirubin >ULN, except with an established diagnosis of Gilbert's syndrome
  • Platelet count less than the lower limit of normal (LLN)
  • Creatinine clearance as calculated by the modification of diet in renal disease (MDRD) estimated glomerular filtration rate (eGFR) equation <60 mL/min
  • Uncontrolled Type 2 diabetes defined as hemoglobin A1c (HbA1c) >9.5%
  • Clinical hyperthyroidism or hypothyroidism or screening hormone results pointing to thyroid dysfunction.
  • Uncontrolled hypertension
  • Participants with known intolerance to MRI or with conditions contraindicated for MRI procedures

Treatment and study plan

Elobixibat

Drug

Elobixibat is a small molecule and a potent inhibitor of the ileal bile acid transporter (iBAT).

Other names: A3309

Placebo oral tablet

Drug

Placebo identical in appearance to active drug

Other names: Placebo

Primary outcomes

  1. Change From Baseline in Serum Low Density Lipoprotein-cholesterol (LDL-C) at Week 16

    Time frame: Week 16

    The primary efficacy endpoint was the change from Baseline in serum LDL-C at Week 16. Baseline was defined as the last non-missing LDL-C value prior to the first dose of study drug.

Secondary outcomes

  1. Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)

    Time frame: From first dose of study drug (Day 1) up to end of follow-up per participant, approximately 13 months

    An adverse event (AE) was any untoward medical occurrence in enrolled participant regardless of causal relationship with study drug. An SAE was defined as any AE that, at any dose, resulted in death, was life-threatening, resulted in persistent or significant disability/incapacity, required or prolonged hospitalization, was a congenital anomaly/birth defect or an important medical event. TEAEs were defined as AEs that were new or worsened after the first dose of study drug.

  2. Absolute Change From Baseline to Week 16 in Liver Fat Fraction

    Time frame: Baseline (Day 1) and Week 16

    The effect of elobixibat on liver steatosis was measured by magnetic resonance imaging (MRI) for liver fat fraction using proton density fat fraction [PDFF]). Baseline was defined as the last non-missing value prior to the first dose of study drug.

  3. Absolute Change From Baseline to Week 16 in Total Liver Fat

    Time frame: Baseline (Day 1) and Week 16

    The effect of elobixibat on liver steatosis was measured by MRI for total liver fat using whole liver fat volume. Baseline was defined as the last non-missing value prior to the first dose of study drug.

  4. Change From Baseline to Week 16 in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma-glutamyl Transferase (GGT)

    Time frame: Baseline (Day 1) and Week 16

    Serum samples were collected at specified timepoints to assess ALT, AST and GGT levels. Baseline was defined as the last non-missing value prior to the first dose of study drug.

  5. Change From Baseline to Week 16 in High-density Lipoprotein (HDL) Cholesterol, Non-high-density Lipoprotein Cholesterol and Triglycerides

    Time frame: Baseline (Day 1) and Week 16

    Blood samples were collected at specified timepoints to assess HDL and non-HDL cholesterol levels and triglycerides. Baseline was defined as the last non-missing value prior to the first dose of study drug.

  6. Change From Baseline to Week 16 in Low-density Lipoprotein (LDL) Cholesterol to High-density Lipoprotein Cholesterol Ratio

    Time frame: Baseline (Day 1) and Week 16

    Blood samples were collected at specified timepoints to assess LDL and HDL cholesterol levels and ratio was obtained. Baseline was defined as the last non-missing value prior to the first dose of study drug.

  7. Change From Baseline to Week 16 in Total Bile Acids

    Time frame: Baseline (Day 1) and Week 16

    Blood samples were collected at specified timepoints to assess total bile acid levels. Baseline was defined as the last non-missing value prior to the first dose of study drug.

Sponsors and collaborators

Lead sponsor

Albireo

Industry

Registry information

Official study title

A Double-Blind, Randomized, Placebo-Controlled, Phase 2 Study to Explore the Efficacy and Safety of Elobixibat in Adults With Nonalcoholic Fatty Liver Disease (NAFLD) or Nonalcoholic Steatohepatitis (NASH)

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jul 5, 2019
Registry last updated
Feb 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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